Overview

This trial is active, not recruiting.

Condition partially edentulous jaw
Treatments microtextured dental implant treatment, dental implant treatment
Sponsor University of Alabama at Birmingham
Collaborator Zimmer Dental
Start date May 2011
End date June 2014
Trial size 60 participants
Trial identifier NCT01821417, Z-11

Summary

The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.

The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Randomized for microtextured dental implant treatment
microtextured dental implant treatment Screw-vent dental implant
Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
(Active Comparator)
Randomized dental implant treatment with machined-collar implants
dental implant treatment
Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Primary Outcomes

Measure
Change in millimeters of bone loss surrounding the implant device
time frame: Implant insertion, 12 months post-insertion

Secondary Outcomes

Measure
Millimeters of periodontal pocket depth surrounding the implant device
time frame: 2 months post- implant insertion
Changes in peri-implant gingivitis scores
time frame: implant insertion, 12 months post-insertion

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: 1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient 2. Existence of one or more missing teeth scheduled to be replaced with dental implants 3. Healthy enough to undergo proposed therapy without compromising existing health 4. Able to consent for their own inclusion 5. Able to read and understand the informed consent form 6. Demonstrated willingness to comply with protocol requirements and timeline Exclusion Criteria: 1. Any health condition that in the opinion of the investigators may adversely affect bone healing 2. Any medication that in the opinion of the investigators may adversely affect bone healing 3. Any indication of an inability to make autonomous decisions 4. Reported pregnancy at the time of enrollment -

Additional Information

Official title A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
Principal investigator Nicolaas C. Geurs, DDS.MS
Description Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.